QMS & EMS London

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

The European Medicines Agency divides the ICH harmonised tripartite guideline in five main paragraphs:  Pharmaceutical Quality System Management Responsibility Continual improvement of process performance and product quality Continual improvement of the pharmaceutical quality system Glossary

Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made. Today we are analysing two representative quality management directives in Pharmaceutical Industry.